Study of Anti-HER2-CAR-T Cell Therapy for Adults With HER2-Positive Locally Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating anti-HER2-CAR-T cell therapy in adults aged 18 to 70 years with HER2-positive locally advanced or metastatic solid tumors, including breast, gastric, colorectal, and pancreatic cancers. This Phase 1, open-label study aims to assess the safety and effectiveness of this cellular treatment when conventional options have been ineffective or are not tolerable. The trial is sponsored by China Medical University, China. Participants receive a single intravenous infusion of anti-HER2-CAR-T cells at varying doses based on a dose escalation design, with possible additional infusions decided by the investigator. Before infusion, patients undergo lymphocyte clearance treatment using cyclophosphamide and fludarabine. Treatment dosing groups include 1x106, 3x106, or 1x107 CAR-T cells per kilogram, and the infusion dose refers to the count of CAR-positive cells. During the study, participants will have an initial screening period, mononuclear cell collection, and may receive bridging therapy if needed before treatment. Researchers will monitor safety by tracking dose-limiting toxicities within 21 days post-infusion and evaluate tumor responses at multiple timepoints up to 12 months. Assessments include imaging for measurable lesions, blood tests, and overall health status. The study includes close follow-up and may last until October 2026.

A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors